Back to resultsIncidence of Diarrhea Using High and Low Osmolality Enteral Tube Feeding in Critically Ill Surgical Patients
Primary Purpose
Tube Feeding
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osmolite 1.5
Promote without fiber
Sponsored by
About this trial
This is an interventional supportive care trial for Tube Feeding focused on measuring Tube Feeding, Diarrhea, Enteral Nutrition, Critically Ill, Surgical, Cardiovascular
Eligibility Criteria
Inclusion Criteria:
- age >18 years
- admitted to SICU or CVICU requiring TF for enteral nutrition
- anticipated ICU stay and TF requirement >72 hours
Exclusion Criteria:
- Contraindication to receiving one of the study TF formulations
- Inability to tolerate at least 75% of estimated requirement by day 3 of enteral TF administration
- Clostridium difficile infection or other cause of infectious diarrhea prior to study enrollment
- Presence of an ileostomy or colostomy
- History of inflammatory bowel disease, bowel resection, short gut syndrome, or chronic diarrhea
Sites / Locations
- University of Utah Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Promote without fiber
Osmolite 1.5
Arm Description
Lower osmolality enteral tube feed formulation
Higher osmolality enteral tube feed formulation
Outcomes
Primary Outcome Measures
Incidence of diarrhea at 72 hours
Secondary Outcome Measures
Incidence of diarrhea at 14 days
Mean frequency of diarrhea days
Total number of diarrhea days
Mean diarrhea scores
Hart and Dobb Diarrhea Scale (a tool based on consistency and size of each stool, with a sum of all stools in one day equaling the score for each day and a score of 12 or more indicates diarrhea)
Time at 75% or more of goal tube feeding rate
Incidence of hypokalemia
Incidence of perineal dermatitis
Number of Clostridium difficile assays sent
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03487744
Brief Title
Incidence of Diarrhea Using High and Low Osmolality Enteral Tube Feeding in Critically Ill Surgical Patients
Official Title
Comparison of the Incidence of Diarrhea Using High and Low Osmolality Enteral Tube Feeding in Critically Ill Surgical Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
slow enrollment
Study Start Date
July 2, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose and primary objective of this study is to determine if there is an association between enteral tube feed (TF) osmolality and diarrhea in critically ill patients. The investigators hypothesize that the administration of a TF formulation with high osmolality will cause more diarrhea than a TF formulation with a lower osmolality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tube Feeding
Keywords
Tube Feeding, Diarrhea, Enteral Nutrition, Critically Ill, Surgical, Cardiovascular
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Promote without fiber
Arm Type
Active Comparator
Arm Description
Lower osmolality enteral tube feed formulation
Arm Title
Osmolite 1.5
Arm Type
Active Comparator
Arm Description
Higher osmolality enteral tube feed formulation
Intervention Type
Other
Intervention Name(s)
Osmolite 1.5
Intervention Description
Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube.
Intervention Type
Other
Intervention Name(s)
Promote without fiber
Intervention Description
Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube.
Primary Outcome Measure Information:
Title
Incidence of diarrhea at 72 hours
Time Frame
72 hour
Secondary Outcome Measure Information:
Title
Incidence of diarrhea at 14 days
Time Frame
14 days
Title
Mean frequency of diarrhea days
Time Frame
14 days
Title
Total number of diarrhea days
Time Frame
14 days
Title
Mean diarrhea scores
Description
Hart and Dobb Diarrhea Scale (a tool based on consistency and size of each stool, with a sum of all stools in one day equaling the score for each day and a score of 12 or more indicates diarrhea)
Time Frame
14 days
Title
Time at 75% or more of goal tube feeding rate
Time Frame
14 days
Title
Incidence of hypokalemia
Time Frame
14 days
Title
Incidence of perineal dermatitis
Time Frame
14 days
Title
Number of Clostridium difficile assays sent
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age >18 years
admitted to SICU or CVICU requiring TF for enteral nutrition
anticipated ICU stay and TF requirement >72 hours
Exclusion Criteria:
Contraindication to receiving one of the study TF formulations
Inability to tolerate at least 75% of estimated requirement by day 3 of enteral TF administration
Clostridium difficile infection or other cause of infectious diarrhea prior to study enrollment
Presence of an ileostomy or colostomy
History of inflammatory bowel disease, bowel resection, short gut syndrome, or chronic diarrhea
Facility Information:
Facility Name
University of Utah Health
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Incidence of Diarrhea Using High and Low Osmolality Enteral Tube Feeding in Critically Ill Surgical Patients
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